A traditional model for managing distribution of surgical devices and surgical accessories includes several phases. These phases typically include inventory management, surgical preparation, and post-surgery inventory management.
During the inventory management phase, a representative of a medical device company orders various medical devices believed to be necessary for a particular surgery. The ordered medical devices are each labeled with an identifier, such as a stock-keeping unit (SKU) number, a lot number, and/or a serial number. All of the ordered medical devices can be packaged into a carrying tray, which can also be labeled with its own identifier, and shipped to the representative from the medical device company or a distributor affiliated therewith. The identifiers of the ordered medical devices and/or the carrying tray can be logged prior to shipment, thereby allowing the medical device company or the distributor to track which medical devices and/or carrying trays have been shipped.
During the surgical preparation phase, the representative can ensure that all of the necessary devices are present in the tray. The instrument tray can be transferred to a hospital processing center, where the tray can be sterilized and prepared for surgery.
After the surgery, the representative identifies and manually documents the inventory that was consumed, including details of the surgery, e.g., date, time, and a name of a surgeon who performed the surgery. The representative obtains a purchase order from the hospital staff so that a seller, e.g., a surgical device company, can bill for the consumed inventory. The representative also ensures that consumed inventory is replenished and that reusable medical devices are either returned to the medical device company or distributor or are prepared for subsequent use at the hospital.
There are a number of inefficiencies associated with existing distribution management models. For example, the representative spends a significant amount of time manually inspecting each surgical set and completing the accompanying paperwork. This time could be better spent supporting more complex surgeries in which representative input is crucial, or generating new business for the medical device company. Furthermore, there are significant costs associated with employing a large staff of representatives. For another example, it takes a significant amount of time to log ordered medical devices and carrying trays prior to shipment and to log medical devices and carrying trays returned after surgery. Precise tracking is necessary for, e.g., inventory management and accurate billing, but the monetary and time costs of conventional tracking methods are high.
In addition to being inefficient, conventional distribution management systems are subject to inaccuracy due to human error in manually tracking and comparing identifiers. Each identifier has to be individually checked, e.g., scanned with a bar code reader or manually written down, etc. If any one identifier is accidentally missed or inaccurately recorded, inventory cannot be properly managed. Additionally, during shipment, identifiers can be damaged, such as with torn packaging, which can render the identifiers useless.
Additionally, at least some conventional identifiers traditionally cannot undergo repeated sterilization because the intensity of the sterilization, e.g., extreme heat, damages the identifiers and/or causes them to unattach, e.g., by unsticking, from packaging. This necessitates replacement of identifiers for medical devices and carrying trays and returned to the medical device company or its distributor. Such replacement increases costs.
Accordingly, there remains a need for tagging and tracking surgical devices and surgical accessories.